The FDA has granted clearance for Fraxel re:store Dual—a non-invasive laser resurfacing treatment—to treat actinic keratosis (AK), which are sun spots, or precancerous spots.
Fraxel re:store Dual adds a 1927 nm wavelength, the first ever application of a Thulium laser in the aesthetics market, which is optimized for treatment of pigmentation and other superficial skin conditions, such as AK.
The FDA clearance was based partly on data from a six-month study of 21 patients with AK. Each underwent a series of two to four laser treatments, spaced two to four weeks apart. The results showed that the treatment yielded a mean 83.5 percent decrease in AK lesions on the face and other regions, including the arms, hands, and chest. Other reported improvements were in skin texture and pigmentation; no adverse events were reported.
“In our study, we found the Fraxel re:store Dual to be the most effective treatment of multiple facial AKs, as it is safe and requires minimal downtime while simultaneously improving other signs of photodamage,” said Dr. Roy G. Geronemus, director of the Laser and Skin Surgery Center of New York, in a news release. “While the 83.5 percent removal rate was comparable to other topical therapies and AK treatment options, Fraxel was overwhelmingly well-tolerated by all the patients and offers the added benefit of improving a patients’ overall skin quality, color and texture.”
Indications cleared by the FDA for the 1550-nm Erbium laser featured on the Fraxel re:store include skin resurfacing procedures and the treatment of eye wrinkles, acne scars, surgical scars, skin discoloration and pigmented lesions, such as age spots, sun spots, and AK.
Dr. Heffernan uses Fraxel re:store to treat patients with a variety of skin conditions and imperfections at his Seattle, Washington, office. Patients may see improvements after only two to three treatments.
but then I look at my hands! Oh my how did that happen?)